KR20240021410A - An enteric soluble film coating composition - Google Patents
An enteric soluble film coating composition Download PDFInfo
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- KR20240021410A KR20240021410A KR1020220099687A KR20220099687A KR20240021410A KR 20240021410 A KR20240021410 A KR 20240021410A KR 1020220099687 A KR1020220099687 A KR 1020220099687A KR 20220099687 A KR20220099687 A KR 20220099687A KR 20240021410 A KR20240021410 A KR 20240021410A
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- 239000007888 film coating Substances 0.000 title claims abstract description 32
- 238000009501 film coating Methods 0.000 title claims abstract description 32
- 239000000203 mixture Substances 0.000 title claims abstract description 17
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 9
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims abstract description 9
- 229920002674 hyaluronan Polymers 0.000 claims abstract description 9
- 229960003160 hyaluronic acid Drugs 0.000 claims abstract description 9
- 235000010413 sodium alginate Nutrition 0.000 claims abstract description 9
- 229940005550 sodium alginate Drugs 0.000 claims abstract description 9
- 239000000661 sodium alginate Substances 0.000 claims abstract description 9
- 239000004372 Polyvinyl alcohol Substances 0.000 claims abstract description 8
- 229920002472 Starch Polymers 0.000 claims abstract description 8
- 229920002451 polyvinyl alcohol Polymers 0.000 claims abstract description 8
- 235000019698 starch Nutrition 0.000 claims abstract description 8
- 239000008107 starch Substances 0.000 claims abstract description 8
- 235000021419 vinegar Nutrition 0.000 claims abstract description 7
- 239000000052 vinegar Substances 0.000 claims abstract description 7
- 239000001038 titanium pigment Substances 0.000 claims description 7
- 239000002202 Polyethylene glycol Substances 0.000 claims description 5
- 229920001223 polyethylene glycol Polymers 0.000 claims description 5
- 239000002981 blocking agent Substances 0.000 claims description 4
- 239000004014 plasticizer Substances 0.000 claims description 4
- 239000003086 colorant Substances 0.000 claims description 3
- 239000002671 adjuvant Substances 0.000 claims description 2
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 abstract description 10
- 239000011248 coating agent Substances 0.000 abstract description 9
- 229940079593 drug Drugs 0.000 abstract description 5
- 239000003814 drug Substances 0.000 abstract description 5
- 238000004090 dissolution Methods 0.000 abstract description 4
- 239000002245 particle Substances 0.000 description 13
- 230000002496 gastric effect Effects 0.000 description 8
- 230000000052 comparative effect Effects 0.000 description 6
- 239000007787 solid Substances 0.000 description 6
- 239000003826 tablet Substances 0.000 description 6
- 239000011162 core material Substances 0.000 description 5
- PNEYBMLMFCGWSK-UHFFFAOYSA-N Alumina Chemical compound [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 4
- 239000000843 powder Substances 0.000 description 4
- 239000002994 raw material Substances 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 238000007922 dissolution test Methods 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 2
- 238000010828 elution Methods 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 238000013112 stability test Methods 0.000 description 2
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 1
- 241000735470 Juncus Species 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 229960001138 acetylsalicylic acid Drugs 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000007941 film coated tablet Substances 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000012982 microporous membrane Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 210000004911 serous fluid Anatomy 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000009495 sugar coating Methods 0.000 description 1
- 238000009496 sugar coating process Methods 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/288—Compounds of unknown constitution, e.g. material from plants or animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/501—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5063—Compounds of unknown constitution, e.g. material from plants or animals
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Abstract
본 발명은 약물 코팅 기술 분야에 관한 것으로, 특히 등심초 40 내지 80 중량부, 녹말 10 내지 30 중량부, 폴리비닐알코올 3 내지 7 중량부, 알긴산나트륨 5 내지 10 중량부 및 히알루론산 1 내지 3 중량부를 포함하는 장용성 필름 코팅 조성물에 관한 것이다. 본 발명에 의해 제조된 장용성 필름 코팅은 우수한 용출성, 내열성 및 안정성을 갖는다.The present invention relates to the field of drug coating technology, and in particular, 40 to 80 parts by weight of sirloin vinegar, 10 to 30 parts by weight of starch, 3 to 7 parts by weight of polyvinyl alcohol, 5 to 10 parts by weight of sodium alginate, and 1 to 3 parts by weight of hyaluronic acid. It relates to an enteric film coating composition comprising: The enteric film coating prepared by the present invention has excellent dissolution, heat resistance and stability.
Description
본 발명은 약물 코팅의 기술분야, 특히 장용성 필름 코팅 조성물에 관한 것이다.The present invention relates to the technical field of drug coatings, particularly enteric film coating compositions.
필름 코팅 기술은 1940년대에 개발된 신기술이다. 제약 산업이 발전함에 따라, 필름 코팅 기술이 점점 더 발전하고 번창하였으며, 점차 전통적인 설탕 코팅 공정을 대체하게 되었다.Film coating technology is a new technology developed in the 1940s. With the development of the pharmaceutical industry, film coating technology has become more advanced and prosperous, gradually replacing the traditional sugar coating process.
필름 코팅은 분말, 입자, 펠렛 또는 정제와 같은 핵심 재료의 표면에 필름 층을 코팅하는 것을 말한다. 코팅 필름은 습기를 방지하고, 외관을 개선하고, 식별을 용이하게 하고, 기계적 힘을 방지하고, 나쁜 냄새나 색상을 숨기고, 위장 반응을 감소시키고, 약물 활성 성분의 방출 성능을 향상시킬 수 있다. 전통적인 설탕 코팅과 비교하여 필름 코팅 기술은 생산주기가 짧고, 재료가 적으며, 습기 저항성이 강하다.Film coating refers to coating a film layer on the surface of core materials such as powders, particles, pellets or tablets. The coating film can prevent moisture, improve appearance, facilitate identification, prevent mechanical force, hide bad odor or color, reduce gastrointestinal reaction, and improve the release performance of drug active ingredients. Compared with traditional sugar coating, film coating technology has a shorter production cycle, fewer materials, and stronger moisture resistance.
기존의 장용성 필름 코팅 예비혼합물은 일반적으로 종합적인 성능이 좋지 않다.Conventional enteric film coating premixes generally have poor overall performance.
본 발명은 등심초(Juncus) 40 내지 80 중량부, 녹말 10 내지 30 중량부, 폴리비닐알코올 3 내지 7 중량부, 알긴산나트륨 5 내지 10 중량부 및 히알루론산 1 내지 3 중량부를 포함하는 장용성 필름 코팅 조성물에 관한 것이다.The present invention is an enteric film coating composition comprising 40 to 80 parts by weight of Juncus, 10 to 30 parts by weight of starch, 3 to 7 parts by weight of polyvinyl alcohol, 5 to 10 parts by weight of sodium alginate, and 1 to 3 parts by weight of hyaluronic acid. It's about.
선택적으로, 위 장용성 필름 코팅 조성물은 등심초 50 내지 70 중량부, 녹말 15 내지 25 중량부, 폴리비닐알코올 3 내지 7 중량부, 알긴산나트륨 5 내지 10 중량부 및 히알루론산 1 내지 3 중량부를 포함한다.Optionally, the gastric enteric film coating composition includes 50 to 70 parts by weight of sirloin vinegar, 15 to 25 parts by weight of starch, 3 to 7 parts by weight of polyvinyl alcohol, 5 to 10 parts by weight of sodium alginate, and 1 to 3 parts by weight of hyaluronic acid.
선택적으로, 위 장용성 필름 코팅 조성물은 필름 코팅 보조제 5 내지 10 중량부를 더 포함한다.Optionally, the gastric enteric film coating composition further includes 5 to 10 parts by weight of a film coating adjuvant.
선택적으로, 위 장용성 필름 코팅 조성물은 가소제, 차광제 및 착색제 중 하나 이상을 포함한다.Optionally, the gastric enteric film coating composition includes one or more of a plasticizer, a light blocking agent, and a colorant.
선택적으로, 위 장용성 필름 코팅 조성물이 포함하는 가소제는 폴리에틸렌 글리콜이다.Optionally, the plasticizer included in the gastric enteric film coating composition is polyethylene glycol.
선택적으로, 위 장용성 필름 코팅 조성물이 포함하는 차광제는 티타늄 안료이다.Optionally, the light-blocking agent included in the gastric enteric film coating composition is a titanium pigment.
선택적으로, 위 장용성 필름 코팅 조성물이 포함하는 착색제는 알루미늄 레이크이다.Optionally, the colorant included in the gastric enteric film coating composition is aluminum lake.
본 발명은 또한 상기 조성물로부터 제조된 20 μm 내지 200 μm 두께의 장용성 필름 코팅을 갖는 필름 코팅제에 관한 것이다.The present invention also relates to a film coating having an enteric film coating with a thickness of 20 μm to 200 μm prepared from the above composition.
본 발명에 의해 제조된 장용성 필름 코팅은 용출성, 내열성 및 안정성이 우수하다.The enteric film coating prepared according to the present invention has excellent dissolution, heat resistance, and stability.
이하, 예시와 함께 본 발명의 실시예를 상세히 설명한다. 이러한 실시예들은 본 발명을 예시하기 위한 것일 뿐 본 발명의 범위를 한정하기 위한 것은 아니라는 것으로 이해되어야 한다. 하기 실시예에 명시된 구체적인 조건이 없는 실험방법은 본 발명에서 제시하는 지침, 당업계에서 알려진 실험 메뉴얼 또는 통상의 조건, 기타 실험방법 또는 제조자가 권장하는 조건에 따라 우선순위가 부여되어야 한다.Hereinafter, embodiments of the present invention will be described in detail along with examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Experimental methods without specific conditions specified in the following examples should be given priority according to the guidelines provided by the present invention, experimental manuals or common conditions known in the art, other experimental methods, or conditions recommended by the manufacturer.
다음의 구체적인 예에서, 원료 성분과 관련된 측정 매개변수는 달리 명시되지 않는 한 계량 정확도 범위 내에서 약간의 편차가 있을 수 있다. 온도 및 시간 매개변수를 포함하면, 계측기 테스트 정확도 또는 작동 정확도에 의해 야기되는 용인 가능한 편차가 허용된다.In the following specific examples, measurement parameters related to raw material components may have slight deviations within the range of weighing accuracy unless otherwise specified. Including temperature and time parameters allows for acceptable deviations caused by instrument test accuracy or operating accuracy.
하기 실시예에서, 제조물은 장용성 필름 코팅 용액이다. 폴리비닐알코올의 분자량은 25,000 내지 35,000이고, 알긴산나트륨의 분자량은 450,000 내지 60,000이고, 히알루론산의 분자량은 1.0 MDa 내지 1.8 MDa이다.In the examples below, the product is an enteric film coating solution. The molecular weight of polyvinyl alcohol is 25,000 to 35,000, the molecular weight of sodium alginate is 450,000 to 60,000, and the molecular weight of hyaluronic acid is 1.0 MDa to 1.8 MDa.
실시예 1Example 1
등심초 40g, 녹말 25g, 폴리비닐알코올 3g, 알긴산나트륨 10g, 히알루론산 1g, 폴리에틸렌 글리콜 2g, 티타늄 안료 1g, 및 알루미늄 레이크 4g의 무게를 재었다.40g of sirloin vinegar, 25g of starch, 3g of polyvinyl alcohol, 10g of sodium alginate, 1g of hyaluronic acid, 2g of polyethylene glycol, 1g of titanium pigment, and 4g of aluminum lake were weighed.
상기 원료를 완전히 전단하고 35 내지 60℃의 혼합기에서 혼합하여 분말을 얻었다.The raw materials were completely sheared and mixed in a mixer at 35 to 60°C to obtain powder.
코팅할 고체 입자는 유동층 내에 위치하며 입자를 순환시키기 위하여 유동화된 공기가 유입되었다. 용융 코팅액은 용기의 바닥, 상단 또는 측면의 노즐을 통해 미립화되고, 반응기 내의 순환 입자와 접촉하게 되었다. 코팅된 고체 입자는 공기에 의해 건조되었다.The solid particles to be coated were placed in a fluidized bed, and fluidized air was introduced to circulate the particles. The molten coating liquid was atomized through nozzles at the bottom, top, or side of the vessel and brought into contact with circulating particles within the reactor. The coated solid particles were dried by air.
실시예 2Example 2
등심초 80g, 녹말 20g, 폴리비닐알코올 5g, 알긴산나트륨 5g, 히알루론산 2g, 폴리에틸렌 글리콜 2g, 티타늄 안료 1g, 및 알루미늄 레이크 4g의 무게를 재었다. 80g of sirloin vinegar, 20g of starch, 5g of polyvinyl alcohol, 5g of sodium alginate, 2g of hyaluronic acid, 2g of polyethylene glycol, 1g of titanium pigment, and 4g of aluminum lake were weighed.
상기 원료를 완전히 전단하고 35 내지 60℃의 혼합기에서 혼합하여 분말을 얻었다. The raw materials were completely sheared and mixed in a mixer at 35 to 60°C to obtain powder.
코팅할 고체 입자는 유동층 내에 위치하며 입자를 순환시키기 위하여 유동화된 공기가 유입되었다. 용융 코팅액은 용기의 바닥, 상단 또는 측면의 노즐을 통해 미립화되고 반응기 내의 순환 입자와 접촉하게 되었다. 코팅된 고체 입자는 공기에 의해 건조되었다.The solid particles to be coated were placed in a fluidized bed, and fluidized air was introduced to circulate the particles. The molten coating liquid was atomized through nozzles at the bottom, top, or side of the vessel and brought into contact with circulating particles within the reactor. The coated solid particles were dried by air.
실시예 3Example 3
등심초 90g, 녹말 15g, 폴리비닐알코올 7g, 알긴산나트륨 3g, 히알루론산 3g, 폴리에틸렌 글리콜 2g, 티타늄 안료 1g, 알루미늄 레이크 4g의 무게를 재었다. We weighed 90g of sirloin vinegar, 15g of starch, 7g of polyvinyl alcohol, 3g of sodium alginate, 3g of hyaluronic acid, 2g of polyethylene glycol, 1g of titanium pigment, and 4g of aluminum lake.
상기 원료를 완전히 전단하고 35 내지 60℃의 혼합기에서 혼합하여 분말을 얻었다. The raw materials were completely sheared and mixed in a mixer at 35 to 60°C to obtain powder.
코팅할 고체 입자는 유동층 내에 위치하며 입자를 순환시키기 위하여 유동화된 공기가 유입되었다. 용융 코팅액은 용기의 바닥, 상단 또는 측면의 노즐을 통해 미립화되고 반응기 내의 순환 입자와 접촉하게 되었다. 코팅된 고체 입자는 공기에 의해 건조되었다.The solid particles to be coated were placed in a fluidized bed, and fluidized air was introduced to circulate the particles. The molten coating liquid was atomized through nozzles at the bottom, top, or side of the vessel and brought into contact with circulating particles within the reactor. The coated solid particles were dried by air.
비교예 1Comparative Example 1
실시예 2와의 차이점은 알긴산나트륨이 동일한 양의 티타늄 안료로 치환된 것이다.The difference from Example 2 is that sodium alginate is replaced with the same amount of titanium pigment.
비교예 2Comparative Example 2
실시예 2와의 차이점은 히알루론산이 동일한 양의 티타늄 안료로 치환된 것이다.The difference from Example 2 is that hyaluronic acid is replaced with the same amount of titanium pigment.
실험예Experiment example
실시예 2에서 제조된 필름 코팅에 아스피린을 코팅하였다. 코팅의 외관은 완전하고 매끄러웠으며, 색상은 균일했으며, 이의 증체량, 용해 및 기타 물리적, 화학적 지표는 중국 약전(藥典)의 현행 기준을 충족했다.Aspirin was coated on the film coating prepared in Example 2. The appearance of the coating was complete and smooth, the color was uniform, and its weight gain, dissolution and other physical and chemical indicators met the current standards of the Chinese Pharmacopoeia.
1. 용출 시험: 약전(藥典)의 첫 번째 방법에 따라, 회전바구니의 회전속도는 분당 회전수 120으로 설정하였고, 용출 배지는 용출 시험을 위해 인공 위액과 인공 장액으로 하였다. 5ml의 미세 다공성 막은 45분 내에 여과하기 위해 샘플로 사용되었다. 여과액을 문헌에 따라 측정하고 45분 내의 막 코팅 정제의 용출을 계산하기 위해 샘플 막 코팅 정제와 비교하였다.1. Dissolution test: According to the first method of the Pharmacopoeia, the rotation speed of the rotating basket was set to 120 revolutions per minute, and the dissolution medium was artificial gastric fluid and artificial intestinal fluid for the dissolution test. 5 ml of microporous membrane was used as sample for filtration within 45 minutes. The filtrate was measured according to the literature and compared to a sample membrane coated tablet to calculate the dissolution of the membrane coated tablet within 45 minutes.
2. 내열성 시험: 실시예 2 및 비교예에서 제조된 필름코팅 정제의 저온 및 고온에서의 외관에 미치는 영향을 조사하였다.2. Heat resistance test: The effect on the appearance of the film-coated tablets prepared in Example 2 and Comparative Example at low and high temperatures was investigated.
3. 안정성 시험: 실시예 2 및 비교예 2에서 제조된 약물 필름 코팅의 안정성을 시험하였다. 코팅 전 정제 코어의 방출량을 100% 기준으로 하였다. 두 그룹은 동일한 작동 매개변수로 동일한 배치의 정제 코어를 코팅하였다. 6개월간의 가속 시험 후, 정제 코어는 1개월마다 시험하였다. 데이터는 아래 표에 나와 있다.3. Stability test: The stability of the drug film coating prepared in Example 2 and Comparative Example 2 was tested. The emission amount of the tablet core before coating was based on 100%. Both groups coated the same batch of tablet cores with identical operating parameters. After 6 months of accelerated testing, the tablet cores were tested every month. The data is shown in the table below.
본 발명에 의해 제조된 약물 필름 코팅은 안정성이 양호함을 실험 결과로부터 알 수 있었다. 6개월의 보관 기간 후에, 코팅의 코어에 있는 활성 성분은 덜 산화되거나 수분을 덜 흡수하여, 오직 100%에서 81.7%로 감소하였다.It was found from the experimental results that the drug film coating prepared by the present invention had good stability. After a storage period of 6 months, the active ingredient in the core of the coating was less oxidized or absorbed less moisture, decreasing only from 100% to 81.7%.
위의 실시예는 본 발명의 몇몇 실시예를 나타내는 것일 뿐이며, 그 설명이 보다 구체적이고 상세하지만, 발명 특허의 범위를 한정하는 것으로 이해되어서는 안 된다. 당업자는 본 발명의 보호 범위에 속하는 본 발명의 개념을 벗어나지 않고 여러 수정 및 개선이 이루어질 수 있음을 주의해야 한다. 따라서, 본 발명에 대한 특허의 보호 범위는 첨부된 특허 청구범위의 적용을 받으며, 특허 청구범위의 내용을 설명하기 위하여 명세서 및 첨부된 도면을 사용할 수 있다. The above examples only represent some embodiments of the present invention, and although the description is more specific and detailed, it should not be understood as limiting the scope of the invention patent. Those skilled in the art should note that various modifications and improvements can be made without departing from the concept of the present invention, which falls within the protection scope of the present invention. Accordingly, the scope of patent protection for the present invention is subject to the attached patent claims, and the specification and attached drawings may be used to explain the content of the patent claims.
Claims (6)
An enteric film coating composition comprising 40 to 80 parts by weight of sirloin vinegar, 10 to 30 parts by weight of starch, 3 to 7 parts by weight of polyvinyl alcohol, 5 to 10 parts by weight of sodium alginate, and 1 to 3 parts by weight of hyaluronic acid.
The enteric film coating composition according to claim 1, comprising 50 to 70 parts by weight of the sirloin vinegar and 15 to 25 parts by weight of the starch.
The enteric film coating composition according to claim 1 or 2, further comprising 5 to 10 parts by weight of a film coating adjuvant.
The enteric film coating composition according to claim 3, wherein the film coating auxiliary agent includes one or more of a plasticizer, a light blocking agent, and a colorant.
The enteric film coating composition of claim 4, wherein the plasticizer is polyethylene glycol.
The enteric film coating composition of claim 4, wherein the light blocking agent is a titanium pigment.
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